The present invention relates to infusion devices and more particularly to such devices that enable liquid medicaments to be conveniently and safely self-administered by a patient.
Administration of insulin has traditionally been accomplished using a syringe. Recently, needle carrying pen-like devices have also been employed for this purpose. Both forms of insulin administration require the patients to stick themselves each time they inject insulin, often many times a day. Thus, these traditional forms of insulin administration have been a rather pervasive intrusion in the lives and routines of the patients who have had to adopt and employ them.
More recently, insulin pumps attached by tubing to an infusion set mounted on the patient's skin have been developed as an alternative form of insulin administration. Such pumps may be controlled by a programmable remote electronic system employing short range radio communication between a control device and electronics that control the pump. While such devices may involve fewer needle sticks, they are expensive to manufacture. They are also complex to operate and cumbersome and awkward to wear. Further, the cost of such devices can be many times the daily expense of using a traditional injection means such as a syringe or an insulin pen.
Devices of the type mentioned above also require a significant amount of training to control and thus use the devices. Great care in programming the devices is required because the pumps generally carry sufficient insulin to last a few days. Improper programming or general operation of the pumps can result in delivery of an excessive amount insulin which can be very dangerous and even fatal.
Many patients are also reluctant to wear a pump device because they can be socially awkward. The devices are generally quite noticeable and can be as large as a pager. Adding to their awkwardness is their attachment to the outside of the patients clothes and the need for a catheter like tubing set running from the device to an infusion set located on the patient's body. Besides being obvious and perhaps embarrassing, wearing such a device can also be a serious impediment to many activities such as swimming, bathing, athletic activities, and many activities such as sun bathing where portions of the patient's body are necessarily uncovered.
In view of the above, a more cost effective and simple device has been proposed whereby an injection system is discreetly attached directly to the skin of the patient. The device may be attached to the patient under the patient's clothing to deliver insulin into the patient by the manual pumping of small doses of insulin out the distal end of a temporarily indwelling cannula that is made a part of the pump device. The cannula may be made a part of the drug delivery device before, during or after the attachment of the drug delivery device to the skin of the patient. The device may be made quite small and, when worn under the clothes, entirely unnoticeable in most social situations. It may still carry sufficient insulin to last a patient several days. It can be colored to blend naturally with the patient's skin color so as not to be noticeable when the patient's skin is exposed. As a result, insulin for several days may be carried by the patient discreetly, and conveniently applied in small dosages after only a single needle stick. For a more complete description of devices of this type, reference may be had to co-pending application Ser. No. 11/906,130, filed on Sep. 28, 2007 for DISPOSABLE INFUSION DEVICE WITH DUAL VALVE SYSTEM, which application is owned by the assignee of this application and hereby incorporated herein by reference in its entirety.
Devices of the type described may be intended for single use. That is, after initial filling of the device reservoir device deployment, and self-administered drug dosing to drug depletion, disposal of the device may be required. In such an event, it would be helpful to have a mechanism built into the device that prevents further use of the device after drug depletion. One solution to achieve this end is fully disclosed and claimed in U.S. co-pending application Ser. No. 11/906,104 filed Sep. 29, 2007 for DISPOSABLE INFUSION DEVICE WITH REUSE LOCK-OUT, which application is owned by the assignee of this invention and incorporated herein by reference in its entirety. As taught therein, the dose delivery actuator may be disabled upon operation of the device actuation buttons when the reservoir is empty. Unfortunately, this device disablement may accidentally occur before the device is ever deployed for use. For example, the device disablement may occur by the actuating buttons being accidentally operated prior to the filling of the device reservoir. Such accidental disablement would render the device useless.
Accordingly, the present invention provides further improvement to the devices disclosed in the above referenced co-pending application. More particularly, the present invention provides for improved patient safety and/or convenience. To that end, the invention provides, an infusion device which includes device disablement upon the reservoir becoming empty while allowing the device disablement to be reset if it occurs prior to the deployment of the device.